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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011379
Receipt No. R000013327
Scientific Title Examination about safety and the effectiveness when we switched from a GnRH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Date of disclosure of the study information 2013/08/06
Last modified on 2013/08/05

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Basic information
Public title Examination about safety and the effectiveness when we switched from a GnRH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Acronym Clinical trial when I switched from a GnGH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Scientific Title Examination about safety and the effectiveness when we switched from a GnRH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Scientific Title:Acronym Clinical trial when I switched from a GnGH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Region
Japan

Condition
Condition Prostate Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 At the time of introduction of hormonal therapy prostate cancer, even if we switch from a GnRH antagonist to a GnRH agonist, to examine the safety and efficacy of PSA, testosterone and et all values measured after the switch
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes in LH and testosterone level after switch the GnRH agonist
Key secondary outcomes Changes in LH, testosterone, PSA. FSH level after administration of the GnRH antagonist

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria 1.The patient pathologically
diagnosed as a prostatic cancer
2.The first patient to receive an hormonal therapy
Key exclusion criteria 1.The patient who has the condition by metastasis
2.Gleason Score8over
3.Prostate volume 50cc over
4.The patient who judged that a doctor
in charge was unsuitable
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Yanishi
Organization Kansai Medical University
Division name Urology
Zip code
Address 2-3-1 Sinmachi Hirakata city
TEL 072-804-0101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Yanishi
Organization Kansai Medical University
Division name Urology
Zip code
Address 2-3-1 Sinmachi Hirakata city
TEL 072-804-0101
Homepage URL
Email masaaki.yanishi@gmail.com

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 04 Month 30 Day

Other
Other related information Changes in LH and testosterone level after switch the GnRH agonist

Management information
Registered date
2013 Year 08 Month 05 Day
Last modified on
2013 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013327

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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